Press Release

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 15, 2018--
AVEO Oncology (NASDAQ: AVEO) today announced the triggering of a $2
million milestone payment to AVEO from EUSA Pharma. The milestone
payment relates to the commercial launch and reimbursement in Germany of
FOTIVDA® (tivozanib) as a first line treatment of adult
patients with advanced renal cell carcinoma (RCC). In the European
Union, Norway and Iceland, tivozanib is indicated for the first line
treatment of adult patients with RCC and for adult patients who are
vascular endothelial growth factor receptor (VEGFR) and mTOR pathway
inhibitor-naïve following disease progression after one prior treatment
with cytokine therapy for RCC. Tivozanib is an oral, once-daily, potent
and highly-selective vascular endothelial growth factor receptor
tyrosine kinase inhibitor (VEGFR-TKI).

EUSA Pharma is the licensee for tivozanib in Europe, North and South
Africa, Latin America and Australasia. The milestone payment is subject
to a 30% sublicense fee due to AVEO’s partner Kyowa Hakko Kirin and is
incremental to the previously-disclosed cash, cash equivalents and
marketable securities at September 30, 2018, which AVEO reported would
fund operations into the second quarter of 2019.

“Germany is among a growing list of countries in the European Union that
recognize the benefit of expanding patient access to FOTIVDA®,”
said Michael Bailey, president and chief executive officer. “As our
partner EUSA continues to advance FOTIVDA® in the approved European
commercial market, we continue to work toward retrieving overall
survival data not yet collected at the preliminary OS analysis of our
pivotal TIVO-3 study, and toward the potential submission of a New Drug
Application with the FDA for tivozanib as a treatment for advanced or
metastatic RCC, a milestone we expect to reach in the first half of
2019.”

Under the terms of their December 2015 agreement, EUSA Pharma has agreed
to pay AVEO up to $384 million in future research and development
funding and milestone payments, assuming successful achievement of
specified development, regulatory and commercialization objectives, as
well as a tiered royalty ranging from a low double-digit up to
mid-twenty percent on net sales of tivozanib in the agreement’s
territories. Thirty percent of milestone and royalty payments received
by AVEO, excluding research and development funding, are due to Kyowa
Hakko Kirin (KHK) as a sublicensing fee in Europe. In the United States,
the royalty obligation to KHK ranges from the low- to mid-teens on net
sales.

About Tivozanib (FOTIVDA®)

Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Hakko Kirin and approved for the treatment of adult
patients with advanced renal cell carcinoma (RCC) in the European Union
plus Norway and Iceland. It is a potent, selective and long half-life
inhibitor of all three VEGF receptors and is designed to optimize VEGF
blockade while minimizing off-target toxicities, potentially resulting
in improved efficacy and minimal dose modifications.1,2 Tivozanib
has been shown to significantly reduce regulatory T-cell production in
preclinical models, enabling potentially enhanced activity when used in
combination with immune modulating therapy.3 Tivozanib has
been investigated in several tumors types, including renal cell,
hepatocellular, colorectal and breast cancers.

About AVEO

AVEO Pharmaceuticals, Inc. (the “Company” or “AVEO”) is a
biopharmaceutical company dedicated to advancing a broad portfolio of
targeted medicines for oncology and other areas of unmet medical need.
The Company’s strategy is to retain North American rights to its
oncology portfolio while securing partners in development and
commercialization outside of North America. The Company is seeking to
develop and commercialize its lead candidate tivozanib in North America
as a treatment for advanced or metastatic renal cell carcinoma (“RCC”).
The Company has outlicensed tivozanib (FOTIVDA®) for oncological
indications in Europe and other territories outside of North America.
Tivozanib is approved in the European Union, as well as Norway and
Iceland, for the first-line treatment of adult patients with RCC and for
adult patients who are vascular endothelial growth factor receptor and
mTOR pathway inhibitor-naïve following disease progression after one
prior treatment with cytokine therapy for RCC. The Company has entered
into partnerships for the development and commercialization of AV-203
(CAN017) and ficlatuzumab, both clinical stage assets in oncology. The
Company is currently seeking a partner to develop the AV-353 platform, a
preclinical asset, worldwide for the potential treatment of pulmonary
arterial hypertension and oncology. In addition, a new formulation of
tivozanib is being explored in ocular conditions. The Company has
recently regained the rights to its AV-380 program for the potential
treatment of cachexia and is considering a variety of options to advance
the program’s development.

This press release contains forward-looking statements of AVEO that
involve substantial risks and uncertainties. All statements, other than
statements of historical fact, contained in this press release are
forward-looking statements. The words “anticipate,” “believe,” “expect,”
“intend,” “may,” “plan,” “potential,” “could,” “should,” “would,”
“seek,” “look forward,” “advance,” “goal,” “strategy,” or the negative
of these terms or other similar expressions, are intended to identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. These forward-looking statements
include, among others, statements about: AVEO’s plans and prospects for
advancing its lead development programs, including its -plans to
retrieve overall survival data for the TIVO-3 study; its plans and
estimates regarding the potential submission of a New Drug Application
to the FDA for tivozanib in the first half of 2019; the potential
efficacy, safety, and tolerability profile of tivozanib; potential
payments under AVEO’s license agreement with EUSA Pharma; AVEO’s plans
and strategies for commercialization of tivozanib in the United States
and Europe; the potential for tivozanib in other indications, as either
a monotherapy or combination therapy; AVEO’s plan to seek a partner to
develop the AV-353 platform; AVEO’s plans regarding AV-380; AVEO’s cash
runway; and AVEO’s strategy, prospects, plans and objectives. AVEO has
based its expectations and estimates on assumptions that may prove to be
incorrect. As a result, readers are cautioned not to place undue
reliance on these expectations and estimates. Actual results or events
could differ materially from the plans, intentions and expectations
disclosed in the forward-looking statements that AVEO makes due to a
number of important factors, including risks relating to AVEO’s ability
to enter into and maintain its third party collaboration and license
agreements, and its ability, and the ability of its collaborators,
licensees and other strategic partners, to achieve development and
commercialization objectives under these arrangements; and AVEO’s
ability, and the ability of its licensees, to demonstrate to the
satisfaction of applicable regulatory agencies such as the FDA the
safety, efficacy and clinically meaningful benefit of AVEO’s product
candidates, including tivozanib. AVEO faces other risks relating to its
business as well, including risks relating to the timing and costs of
any product candidate that receives regulatory approval; its ability to
file an NDA for tivozanib in the timeframe it currently estimates; its
and its collaborators’ ability to successfully enroll and complete
clinical trials, including the TIVO-3 and TiNivo studies; AVEO’s ability
to achieve and maintain compliance with all regulatory requirements
applicable to its product candidates; AVEO’s ability to obtain and
maintain adequate protection for intellectual property rights relating
to its product candidates and technologies; AVEO’s ability to
successfully implement its strategic plans; AVEO’s ability to raise the
substantial additional funds required to achieve its goals, including
those goals pertaining to the development and commercialization of
tivozanib; unplanned capital requirements; adverse general economic and
industry conditions; competitive factors; and those risks discussed in
the sections titled “Risk Factors” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations—Liquidity and
Capital Resources” included in AVEO’s quarterly and annual reports on
file with the Securities and Exchange Commission (SEC) and in other
filings that AVEO may make with the SEC in the future. The
forward-looking statements in this press release represent AVEO’s views
as of the date of this press release. AVEO anticipates that subsequent
events and developments may cause its views to change. While AVEO may
elect to update these forward-looking statements at some point in the
future, it specifically disclaims any obligation to do so. You should,
therefore, not rely on these forward-looking statements as representing
AVEO's views as of any date other than the date of this press release.
Any reference to AVEO’s website address in this press release is
intended to be an inactive textual reference only and not an active
hyperlink.